DOCSLIB.ORG

Alternative Approaches to the Management of Priapism

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Alternative Approaches to the Management of Priapism International Journal of Impotence Research (1998) 10, 11±14 ß 1998 Stockton Press All rights reserved 0955-9930/98 $12.00 Alternative approaches to the management of priapism JD deHoll,1 PA Shin,1 JF Angle2 and WD Steers1 Departments of 1Urology and 2Radiology, University of Virginia School of Medicine, Charlottesville, Virginia, USA Herein we describe the use of intracavernous methylene blue (MB), a guanylate cyclase inhibitor, or internal pudendal artery embolization for the treatment of priapism. Eleven patients with priapism were treated from 1993±1996. Etiologies of priapism included PGE1/papaverine (3), trazodone (2), and sickle cell disease (1), in the other ®ve cases the cause was unknown. The average duration of priapism was 27 h for all patients (6±72 h). Five patients who failed intracavernous MB or an a-adrenergic agonist, underwent unilateral or bilateral pudendal artery embolization. The average duration of priapism for patients undergoing embolization was 43 h. Sixty-seven percent of the patients treated with MB responded with immediate detumescence. One-hundred percent of patients with priapism secondary to intracavernous injection therapy or trazodone responded. Of the ®ve patients who underwent embolization, 40% achieved immediate pain relief and subsequent detumescence. The three non-responders exhibited a partial detumescence over 47±72 h. After follow-up of one year embolization available for only two patients revealed that one regained potency while the other remained impotent. These results con®rmed that MB is effective for pharmacologically-induced priapism. Embolization is a less invasive option for refractory priapism, although results are less than satisfactory in men with priapism of several days duration. Keywords: methylene blue; pudendal artery; embolization; Gel-Foam Introduction agents which cause a rise in cGMP. We have previously reported temporary success with IC Over the last decade advances in understanding the methylene blue for the treatment of priapism.3 physiology and pharmacology of erection have led Methylene blue is widely used topically and to greatly expanded knowledge of the etiology and intravenously. Its has virtually no signi®cant side treatment of priapism.1 Pharmacologically-mediated effects and is rapidly excreted by the kidneys into priapism is more common with the widespread use the urine. Rarely, a slight rise in blood pressure is of intracavernous (IC) therapy for impotence. This seen after systemic administration. The safety adverse event is treated by (IC) a-adrenergic agonists pro®le of MB and its ability to block the effects of such as phenylephrine.2 The search for other non- nitrovasodilators including NO lead to its routine surgical treatments with minimal systemic side use in the treatment of priapism. As an inhibitor of effects has led us to investigate the use of methylene guanylate cyclase, MB is hypothesized to produce blue.3 detumescence by preventing prolonged activation of Neurally-mediated vasodilatation and corporal a cGMP pathway. It may also release norepinephrine cavernosal smooth muscle relaxation produce tu- via free radical formation. mescence.1 Nitric oxide (NO) released from para- Despite the widespread use of a-adrenergic sympathetic nerves activates a guanylate cyclase agonists for priapism, surgical management is often which leads to elevation of cGMP.4±6 GTP or ATP is necessary. The Winter7,8 percutaneous procedure converted to its cyclic monophosphate moieties, and the Al-Ghorab or Quackles shunts are com- which is thought to produce a fall in cytosolic monly performed. The success rates for these calcium causing relaxation of smooth muscle. procedures vary from 50±65%.8,9 Wear et al.10 ®rst Methylene blue (MB) is an inhibitor of guanylate described the treatment of priapism with pudendal cyclase and thereby blocks the smooth muscle artery embolization in 1977. In an effort to avoid relaxation initiated by nitric oxide (NO) or other surgery, which lacks ef®cacy in at least half of the patients, we prospectively subjected all cases of priapism refractory to IC MB or an a-adrenergic Correspondence: Dr WD Steers, University of Virginia Health agonist to pudendal embolization to see if results Sciences Center, Department of Urology, Box 422, Charlottesville, Virginia 22908, USA. were comparable to surgery. The goal of this study Received 16 May 1997; revised 27 June 1997; accepted was to describe and compare two new non-surgical 11 August 1997 treatment regimens for priapism. Alternative approaches to the management of priapism JD deHoll et al 12 Figure 2 Results of intracavernous methylene blue on priapism. Success after methylene blue is de®ned as complete detumes- cence and pain relief. Figure 1 Site of action for methylene blue. Corpus cavernosum smooth muscle relaxation can be achieved by nitric oxide acting Patients receiving pudendal artery embolization on guanylate cyclose thereby producing a rise in cGMP. Likewise, underwent diagnostic arteriography of the pelvis PGE1 acting on adenylate cyclse can raise cAMP. cAMP is normally degraded by a phosphodiesterase (probably type 3). with bilateral selective injections of the internal Elevations in these cyclic nucleotides cause relaxation. Papa- pudendal arteries. No arterio-venous ®stulas or verine may enhance relaxation and erections by inhibiting a arterial extravasation was identi®ed. Embolization phosphodiesterase. was performed through a 5F multi-purpose catheter (Cook, Bloomington, IN), advanced to the distal internal pudendal artery or to the level of the Methods common penile artery. In patients with small caliber pudendal arteries, a 3F microcather (Target Ther- apeutics, Fremont, CA) was placed coaxially Eleven patients were treated for priapism between through the 5F catheter. Approximately 1 mm 1993 and 1996. The age range was 22±56 y (mean 1mm62 mm pledgets of Gel-Foam (Upjohn Cio, 37 y). The average duration of priapism for the Kalamazoo, MI) were injected until complete stasis entire group was 7 h (range 6±72 h). Priapism was was achieved. Embolization was bilateral in four of de®ned as prolonged painful tumescence lasting ®ve cases. Staged procedures were separated by 24 h more than 6 h. Etiology for patients were: PGE1 to monitor for detumescence and skin necrosis. (n 2), trazodone (n 2), papaverine (n 1), sickle All patients had bright red blood (BRB) aspirated cell (n 1) and idiopathic (n 5). Five patients were from the corpora during initial treatment. All treated initially at our institution. The remaining six men were referred after unsuccessful treatments by community urologists. In patients without previous therapy. MB was ®rst administered after irrigation and aspiration of the copora. Approximately 50 mg of MB 1/2 ampule) was injected IC and left for 3± 5 min. The MB was then aspirated and light compression was held on the penis for 5 min. MB was administered after aspiration of the blood from the copora cavernosa. Two of the 11 were not given MB due to previous extensive surgery for their priapism. These patients underwent immediate unilateral pudendal artery embolization. Because nearly half the patients presented after lengthy delays with substantial penile edema, effective therapy in these patients was de®ned as a greater than 50% detumescence and relief of pain. Table 1 Results of pudendal artery embolization for priapism of long duration Unilateral Bilateral Response embolization embolization Immediate detumescence 0 2 Figure 3 Representative pudendal arteriography demonstrating Delayed detumescence 1 2 site of embolization. Gel Foam is introduced into the common penile artery. DAP diorsal artery of the penis. Alternative approaches to the management of priapism JD deHoll et al 13 patients underwent angiographically demonstrated Although MB appeared to be without signi®cant dilation of the pudendal artery. An attempt was side effects in our series, penile necrosis has been made to call each of these patients after one year. reported after its used.11 Necrosis has been attrib- uted to free radical generation and tissue ischemia. However, this reported adverse event occurred in a Results patient who had 5 y of intermittent priapism with ®brosis, and occurred one week following an unsuccessful shunt procedure. In addition, the Nine patients were treated with MB. If MB was reported patient received intracavernous a-agonists. ineffective then phenylephrine was administered. Alpha-agonists have been used after MB injection However, no patient failing MB was effectively without ill effect, but this should be done with rescued with an a-adrenergic agonist. Six of nine caution. Alpha-agonists offered no bene®t in cases (67%) patients were cured using MB alone. For drug where MB was unsuccessful. Apparently, either MB induced priapism, 100% of the patients were cured or a-agonists can be used as initial therapy, but if with MB alone. In contrast, only 20% of the either is unsuccessful, additional bene®t from the idiopathic patients were cured with MB, with an other is unlikely. An additional side effect of MB average duration of priapism of 42 h. The primary treatment was a temporary blue discoloration of the side effect was transient mild burning with injection penis. Two patients with priapism due to PGE of the MB. complained of burning sensations of the penis Five patients who failed prior IC therapy and/or following injection of MB, which resolved in 1 h. surgical shunt procedures underwent embolization Within 1 year after successful MB treatment, three of the pudendal artery. None of these patients gave a patients regained baseline erectile status. Oral history of trauma to the perineum or penis. The agents such as a-agonists can be considered, but average duration of priapism in this refractory group recent concerns regarding hypertension and cardiac was 43 h. All patients in the embolization series had arrhythmias may limit their usage. It is unknown aspiration of bright red blood from the corpora. whether oral MB would be effective. Dilatation of the pudendal artery and the distal If pharmacologic therapy fails, the decision cavernous artery was seen on arteriography.
Load more

Recommended publications
  • Transurethral Alprostadil with MUSETM (Medicated
    International Journal of Impotence Research (1997) 9, 187±192 ß 1997 Stockton Press All rights reserved 0955-9930/97 $12.00 Transurethral Alprostadil with MUSETM (medicated urethral system for erection) vs intracavernous AlprostadilÐa comparative study in 103 patients with erectile dysfunction H Porst Urological Of®ce, Neuer Jungfernstieg 6a, 20354 Hamburg, Germany A comparative study in 103 unselected patients with erectile dysfunction between MUSETM up to 1000 mg and intracavernous Alprostadil (ProstavasinTM)upto20mg provided total response-rates of 43% (MUSETM) vs 70% (ProstavasinTM). Complete rigid erections were reached in 10% (MUSETM) vs 48% (ProstavasinTM). The average end-diastolic ¯ow values in the deep penile arteries ranged between 9.2±9.4 cm/s after MUSETM and 4.5±4.8 cm/s after i.c. Alprostadil con®rming the investigator's assessment, that in the vast majority of patients MUSETM were not able to induce a complete cavernous smooth muscle relaxation. In terms of side effects the reported penile pain/burning-rate after MUSETM was 31.4% compared to 10.6% after i.c. Alprostadil. In addition after MUSETM clinically relevant systemic side-effects like dizziness, sweating and hypotension occurred in 5.8% with syncope in 1%. No circulatory side-effects were encountered after i.c. Alprostadil. Urethral bleeding after MUSETM-application was observed in 4.8%. Due to the superior ef®cacy and lower side-effects self-injection therapy with Alprostadil remains the `Gold Standard' in the management of male impotence. MUSETM should be reserved
    [Show full text]
  • Current Status of Local Penile Therapy
    International Journal of Impotence Research (2002) 14, Suppl 1, S70–S81 ß 2002 Nature Publishing Group All rights reserved 0955-9930/02 $25.00 www.nature.com/ijir Current status of local penile therapy F Montorsi1*, A Salonia1, M Zanoni1, P Pompa1, A Cestari1, G Guazzoni1, L Barbieri1 and P Rigatti1 1Department of Urology, University Vita e Salute – San Raffaele, Milan, Italy Guidelines for management of patients with erectile dysfunction indicate that intraurethral and intracavernosal injection therapies represent the second-line treatment available. Efficacy of intracavernosal injections seems superior to that of the intraurethral delivery of drugs, and this may explain the current larger diffusion of the former modality. Safety of these two therapeutic options is well established; however, the attrition rate with these approaches is significant and most patients eventually drop out of treatment. Newer agents with better efficacy-safety profiles and using user-friendly devices for drug administration may potentially increase the long-term satisfaction rate achieved with these therapies. Topical therapy has the potential to become a first- line treatment for erectile dysfunction because it acts locally and is easy to use. At this time, however, the crossing of the barrier caused by the penile skin and tunica albuginea has limited the efficacy of the drugs used. International Journal of Impotence Research (2002) 14, Suppl 1, S70–S81. DOI: 10.1038= sj=ijir=3900808 Keywords: erectile dysfunction; local penile therapy; topical therapy; alprostadil Introduction second patient category might be represented by those requesting a fast response, which cannot be obtained by sildenafil; however, sublingual apomor- Management of patients with erectile dysfunction phine is characterized by a fast onset of action and has been recently grouped into three different may represent an effective solution for these 1 levels.
    [Show full text]
  • Trimix Injection Information for Patients
    Individualized Medications to Fit Your Needs 5 0 3 BEXCELLENCEYOUCANRELYON TRIMIX INJECTION PHYSCIAN INFORMATION WWW.OLYMPIAPHARMACY.COM TriMix Injection Physician Information TriMix injections are an alternative to PDE5 Inhibitor tablets (Viagra®, Levitra®, Cialis®) and most commonly include the mixture of 3 drugs; phentolamine, papaverine and alprostadil. TriMix is especially useful when patients are unable to take PDE5 Inhibitors because they are taking nitrates, certain beta blockers, or experience severe side effects from the oral medications. Alternative to Tablets TriMix injections are an alternative to PDE5 Inhibitor tablets (Viagra®, Levitra®, Cialis®) and most commonly include the mixture of 3 drugs; phentolamine, papaverine and alprostadil. TriMix is especially useful when patients are unable to take PDE5 Inhibitors because they are taking nitrates, certain beta blockers, or experience severe side effects from the oral medications How It Works: An intracavernous injection, is the most effective non-surgical treatment for ED, according to the American Urologic Association. Injections into the penis, unlike oral medications, trigger an automatic erection in less than 5 minutes. TriMix is a mixture of three vasodilators that when injected, cause the corpus cavernosum to relax, expand and fill with blood, creating a powerful erection Dosage: The initial dose should be 0.1 cc Wait 3 days before increasing dosage. Increase by 0.025 cc until a satisfactory dose is reached. The maximum dose is 0.50 cc. Do not be discouraged by a poor result with the first few injections, as the initial dose has been kept low to avoid a prolonged erection Reversing The Test Dose: Phenylephrine is commonly used to reverse the effects of TriMix to prevent an erection lasting too long while the patient is learning their correct dosage.
    [Show full text]
  • Male Sexual Impotence: a Case Study in Evaluation and Treatment
    FAMILY PRACTICE GRAND ROUNDS Male Sexual Impotence: A Case Study in Evaluation and Treatment John G. Halvorsen, MD, MS, Craig Mommsen, MD, James A. Moriarty, MD, David Hunter, MD, Michael Metz, PhD, and Paul Lange, MD Minneapolis, Minnesota R. JOHN HALVORSEN {Assistant Professor, De­ cavernosa. There is also a very important suspensory lig­ D partment o f Family Practice and Community ament—a triangular structure attached at the base of the Health)-. Male sexual impotence is the inability to obtain penis and to the pubic arch blending with Buck’s fascia and sustain an erection adequate to permit satisfactory around the penis—that is responsible for forming the angle penetration and completion of sexual intercourse. Im­ of the erect penis. potence is defined as primary if erections have never oc­ The arterial supply to the penis flows from the aorta curred, and secondary if they have previously occurred through the common iliac, hypogastric, and internal pu­ but subsequently have ceased. The cause of sexual im­ dendal systems. The artery of the penis is a branch of the potence may be psychogenic, organic, or mixed. In the internal pudendal artery and has four branches. The first past, the common belief was that 90 percent of impotence branch, the artery to the bulb, supplies the corpus spon­ was psychological.1,2 Recent research indicates, however, giosum, the glans, and the bulb. The second branch is the that over one half of men with impotence suffer from an urethral artery. The artery of the penis then terminates organic disorder, although often there is considerable into the dorsal artery of the penis (which supplies the deep overlap between both psychological and organic causes.3,4 fascia, the penile skin, and the frenulum) and the deep or A knowledge of the anatomy of the penis and the com­ profunda branch (which supplies the corpora cavernosa plex physiology of erection is necessary to understand the on each side).
    [Show full text]
  • Product Monograph
    PRODUCT MONOGRAPH PrCAVERJECT® STERILE POWDER (Alprostadil for Injection) 20 mcg Vials Prostaglandin Pfizer Canada Inc. Date of Revision: 17,300 Trans-Canada Highway June 01, 2016 Kirkland, Quebec H9J 2M5 Control No. 193414 ® TM Pharmacia Enterprises SARL Pfizer Canada Inc., Licensee Pfizer Canada Inc. 2016 PRODUCT MONOGRAPH PrCAVERJECT STERILE POWDER (Alprostadil for Injection) Prostaglandin ACTION AND CLINICAL PHARMACOLOGY Alprostadil is a prostaglandin with various pharmacological actions that include vasodilation and inhibition of platelet aggregation, inhibition of gastric secretion, stimulation of intestinal smooth muscle and stimulation of uterine smooth muscle. Alprostadil, when given to impotent men by intracavernous injection, induces erections within 5 to 20 minutes after administration. The duration of erection is dose-dependent. The mechanism of penile erection involves a complex series of neurovascular events. Alprostadil injected intracavernosally causes tumescence by increasing cavernous blood flow through relaxation of trabecular smooth muscle and dilation of cavernosal arteries. With regards to the action of alprostadil on penile structures, in most animal species tested, alprostadil had relaxant effects on retractor penis and corpus cavernosum urethrae in vitro. Alprostadil also relaxed isolated preparations of human corpus cavernosum and spongiosum as well as cavernous arterial segments previously contracted by either noradrenaline or PGF2α. In pigtail monkeys (Macaca nemestrina), alprostadil increased cavernous arterial blood flow in vivo. The degree and duration of cavernous smooth muscle relaxation in this animal model was dose-dependent. Other actions of PGE1 involve the cardiovascular system, central nervous system (CNS), autonomic nervous system, respiratory system, gastrointestinal system and hematopoietic system. Pharmacokinetics Absorption The absolute bioavailability of alprostadil following intracavernosal injection has not been determined.
    [Show full text]
  • (Medical and Mechanical) Treatment of Erectile Dysfunction
    130 SOP Conservative (Medical and Mechanical) Treatment of Erectile Dysfunctionjsm_12023 130..171 Hartmut Porst, MD,* Arthur Burnett, MD, MBA, FACS,† Gerald Brock, MD, FRCSC,‡ Hussein Ghanem, MD,§ Francois Giuliano, MD,¶ Sidney Glina, MD,** Wayne Hellstrom, MD, FACS,†† Antonio Martin-Morales, MD,‡‡ Andrea Salonia, MD,§§ Ira Sharlip, MD,¶¶ and the ISSM Standards Committee for Sexual Medicine *Private Urological/Andrological Practice, Hamburg, Germany; †The James Buchanan Brady Urological Institute, The Johns Hopkins Hospital, Baltimore, MD, USA; ‡Division of Urology, University of Western, ON, Canada; §Sexology & STDs, Cairo University, Cairo, Egypt; ¶Neuro-Urology-Andrology Unit, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France; **Instituto H.Ellis, São Paulo, Brazil; ††Department of Urology, Section of Andrology and Male Infertility, Tulane University School of Medicine, New Orleans, LA, USA; ‡‡Unidad Andrología, Servicio Urología Hospital, Regional Universitario Carlos Haya, Málaga, Spain; §§Department of Urology & Urological Reseach Institute (URI), Universiti Vita Saluta San Raffaele, Milan, Italy; ¶¶University of California at San Francisco, San Francisco, CA, USA DOI: 10.1111/jsm.12023 ABSTRACT Introduction. Erectile dysfunction (ED) is the most frequently treated male sexual dysfunction worldwide. ED is a chronic condition that exerts a negative impact on male self-esteem and nearly all life domains including interper- sonal, family, and business relationships. Aim. The aim of this study
    [Show full text]
  • Isoflurane Inhalation Anesthesia Should Be a New Requirement In
    www.nature.com/scientificreports OPEN Isofurane inhalation anesthesia should be a new requirement in intracavernosal pressure Received: 21 December 2016 Accepted: 19 October 2017 detection—the gold standard of Published: xx xx xxxx erectile function assessment Jinhong Li1,2, Changjing Wu1, Fudong Fu1, Xuanhe You1, Liang Gao1,2, Romel Wazir3, Feng Qin1, Ping Han2 & Jiuhong Yuan1,2 Intracavernosal pressure (ICP) is gold standard for the detection of erectile function in animals, but no consensus has yet been achieved on what kind of anesthetic protocol should be applied. A total of 16 adult male Sprague-Dawley rats were randomized into two groups. In group A, chloral hydrate was injected intraperitoneally. Rats in group B were induced in 5% isofurane for 3 min and then maintained in 1.0–1.5% isofurane. Mean arterial pressure (MAP), respiratory rate (RR) and heart rate were monitored during all experiments. After ICP detection, tail vein and carotid artery blood were collected. The maximum ICP value, MAP and ICP/MAP ratio in group B was signifcantly higher than in that of group A. The RR in group A was lower than in that of group B, but the heart rate in group A was higher than in group B. There were no signifcant diferences in both pO2 and pCO2 between groups. While the data showed that animals in group A were relatively hypoxemic. Isofurane inhalation anesthesia in detection of erectile function could ofer a relatively more stable physical state than in that under the efect of chloral hydrate intraperitoneal anesthesia. Isofurane inhalation anesthesia is more suitable for ICP test.
    [Show full text]
  • Priapism After Epidural Or Spinal Anesthesia
    Western Michigan University ScholarWorks at WMU Research Day WMU Homer Stryker M.D. School of Medicine 2017 Priapism After Epidural or Spinal Anesthesia Sarah Khalil Western Michigan University Homer Stryker M.D. School of Medicine Kelly Quesnelle Western Michigan University Homer Stryker M.D. School of Medicine Jeffrey Friedman Western Michigan University Homer Stryker M.D. School of Medicine Audrey Jensen Western Michigan University Homer Stryker M.D. School of Medicine Duncan Polot Western Michigan University Homer Stryker M.D. School of Medicine See next page for additional authors Follow this and additional works at: https://scholarworks.wmich.edu/medicine_research_day Part of the Life Sciences Commons, and the Medicine and Health Sciences Commons WMU ScholarWorks Citation Khalil, Sarah; Quesnelle, Kelly; Friedman, Jeffrey; Jensen, Audrey; Polot, Duncan; and Spitler, Sydney, "Priapism After Epidural or Spinal Anesthesia" (2017). Research Day. 77. https://scholarworks.wmich.edu/medicine_research_day/77 This Abstract is brought to you for free and open access by the WMU Homer Stryker M.D. School of Medicine at ScholarWorks at WMU. It has been accepted for inclusion in Research Day by an authorized administrator of ScholarWorks at WMU. For more information, please contact [email protected]. Authors Sarah Khalil, Kelly Quesnelle, Jeffrey Friedman, Audrey Jensen, Duncan Polot, and Sydney Spitler This abstract is available at ScholarWorks at WMU: https://scholarworks.wmich.edu/medicine_research_day/77 Priapism After Epidural and
    [Show full text]
  • Let's Talk About ED
    LET’S TALK ABOUT ED Get the facts. And get back to your life. This content is intended for patient counseling purposes only. This content is for informational/educational purposes and is not intended to treat or diagnose any disease or person. No claims are made as to the safety or eicacy of mentioned preparations. The compounded medications featured in this piece have been prescribed and administered by physicians who work with Wedgewood Pharmacy. You are encouraged to speak with your health care provider as to the appropriate use of any medication. TELL ED TO TAKE A HIKE 2 Let’s Talk About ED You’re not alone. A lot of guys know ED. Nearly More than % 30million 50 men have erectile of men between the ages dysfunction (ED) in the of 40 and 70 experience United States. it to some degree1. The bottom line is this – you’re not alone, and you don’t have to go it alone. This guide focuses on a treatment option prescribed for erectile dysfunction, penile self-injection medications, also known as intracavernosal injections. If you have any questions after reading this guide, bring them to your doctor’s attention. Don’t let ED be the boss of you. It’s natural to feel some anxiety about erectile dysfunction. But ED is a medical condition that can be treated – and treatment can result in signiicantly improved quality of life2 for both you and your partner. Many men report that enhancing or even saving a relationship, enjoying a satisfying sex life and regaining conidence far outweigh any anxieties about pursuing treatment – it’s well worth it.
    [Show full text]
  • Summary of Product Characteristics
    SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT <Product name>25 micrograms / 2 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Product name> 25 micrograms / 2 mg: 1 dose (ampoule 0.35 ml) contains 25 micrograms of aviptadil and 2 mg of phentolamine mesilate. Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Appearance: Colorless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications <Product name> is indicated for the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology. 4.2 Posology and method of administration Posology <Product name> 25 micrograms / 2 mg. The injection should provide the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the duration of the erection does not exceed one hour. Injection frequency should not exceed once daily or 3 times weekly. Paediatric population: <Product name> is not recommended in children. Elderly: No formal studies have been performed in patients above 75 years of age. Impaired renal or hepatic function: No formal studies have been performed in patients with impaired renal or hepatic function. Method of administration The ampoule can be brought to room temperature before use, or it can be used directly from the refrigerator (see section 6.6). The intracavernosal injection must be done under sterile conditions. <Product name> should be administered by direct intracavernous injection.
    [Show full text]
  • Caverjecttm (Alprostadil)
    Pfizer Confidential Disclaimer While these labels are the most current Drug Control Authority (DCA) approved versions of content, these are not necessarily reflective of final printed labeling currently in distribution LPD Title : ALPROSTADIL LPD Date : 14 December 2016 Country : Malaysia Ref. Doc. : UK SmPC Dated November 2016 and UK PIL Dated March 2016 Reason : Addition of text regarding needle breakage to section 4.4 special warnings and precautions for use. To update the storage condition to “Store below 30°C” and section 6.5. Remove 5mcg and 10mcg SKU as product no longer registered 1. NAME OF THE MEDICINAL PRODUCT CAVERJECTTM (ALPROSTADIL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CAVERJECT™ 20 μg Each powder vial contains: Alprostadil 20 μg – Lactose monohydrate - Sodium citrate - α-cyclodextrine - Hydrochloric acid - Sodium hydroxide. Each diluent syringe (1 ml) contains: Benzyl alcohol 9 mg - Water for injection. 3. PHARMACEUTICAL FORM Pharmaceutical form after reconstitution: injectable solution. Way of administration: intracavernosal. 4. CLINICAL PARTICULARS Distribution 4.1 Therapeutic Indication Alprostadil is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. Alprostadil may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. For 4.2 Posology and Method of Administration Alprostadil is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally recommended. The dose of alprostadil should be individualised for each patient by careful titration under supervision by a physician. The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorsolateral aspect of the proximal third of the penis.
    [Show full text]
  • Intracavernosal Vascular Endothelial Growth Factor (VEGF)
    International Journal of Impotence Research (2003) 15, 26–37 & 2003 Nature Publishing Group All rights reserved 0955-9930/03 $25.00 www.nature.com/ijir Intracavernosal vascular endothelial growth factor (VEGF) injection and adeno-associated virus-mediated VEGF gene therapy prevent and reverse venogenic erectile dysfunction in rats RS Rogers1, TM Graziottin1, C-S Lin1, YW Kan2 and TF Lue1* 1Knuppe Molecular Urology Laboratory, Department of Urology, University of California School of Medicine, San Francisco, California, USA; and 2Department of Laboratory Medicine, University of California School of Medicine, San Francisco, California, USA Penile veno-occlusive dysfunction (venogenic erectile dysfunction) is a common cause of erectile dysfunction (ED). We investigated whether vascular endothelial growth factor (VEGF) can be used to prevent and reverse venogenic ED in a rat model. Pharmacological cavernosometry was developed and validated using adult male rats with either arteriogenic or venogenic ED. Castrated animals were treated with intracavernous VEGF as either a recombinant protein (C+VEGF) or adeno-associated virus (AAV)-mediated VEGF gene therapy (C+VEGF gene) in an attempt to prevent the development of venogenic ED. Other animal groups received testosterone replacement (C+testosterone) or intracavernous AAV-LacZ gene (C+LacZ). Animals with documented venogenic ED were treated with intracavernous VEGF in an attempt to reverse their ED. Functional analysis (pharmacological infusion cavernosometry) was performed following treatment. Penile specimens were harvested for immunohistochemistry and electron microscopic evaluation. Castrated rats showed a decrease in papaverine-induced intracavernous pressure and an increase in maintenance and drop rates during pharmacological cavernosometry. These changes were prevented by systemic testosterone and intracavernous VEGF or AAV-VEGF therapy.
    [Show full text]